The present invention relates generally to fluid processing systems, and more specifically to a self-contained prepackaged fluid processing module which can be conveniently stored, set-up and operated.
Various methods and apparatus have been developed which utilize disposable single-use processing systems formed of plastics such as vinyl for accomplishing fluid processing procedures. In the medical field, for example, processing systems have been developed for blood fractionation procedures, such as plasmapheresis, leukopheresis and plateletpheresis, wherein whole blood is separated into one or more fractions by means of either a filter element or by means of centrifugation, and for hemodialysis procedures, wherein diffusion exchange occurs through a membrane between whole blood and a dialysis solution.
In these, and in other medical procedures employing disposable fluid processing systems, it is typically necessary for an attendant to first select and locate an appropriate filter or membrane element and one or more flow sets. The packaging of these items must then be opened and the items must be connected together to form a fluid circuit, which is then installed on the particular processor apparatus with which the procedure is to be performed.
Typically, the processor apparatus includes multiple pump, detector and clamping elements on which particular components and tubing segments of the fluid circuit must be individually installed. Consequently, the set-up procedure may be undesirably complex so as to require a specially trained operator, and may require an undesirably long time period to complete. Furthermore, even with the use of a specially trained technician, the potential remains for error, as where the wrong tubing segment is installed on a particular element of the apparatus.
Accordingly, the need has developed in the medical field for a modular fluid processing system which contains in a single storable package all of the components required for a particular procedure, and wherein the connections between system components are clearly identified and pre-established so that the system can be quickly set-up and installed on an associated processor apparatus. Preferably, such a system and the associated apparatus should be constructed so as to avoid the need for installing individual tubing segments and components of the system on individual pump, monitor and clamp elements of the apparatus. Furthermore, such a fluid processing system should contain all fluid containers necessary for fluids dispensed and collected in the procedure, so that the operator need only install the system in the actuator apparatus and connect input and output tubing segments to the donor prior to beginning a procedure.
Previous attempts at reducing the complexity of fluid processing systems for medical procedures have centered on arranging a portion of the fluid circuit in a block or manifold so as to interface with a complementarily configured actuator station on a processor apparatus. Typically, such systems did not provide containers for storing fluids, such as saline or ACD, and components required in the procedures. Consequently, it was necessary for the operator to separately assemble these component and make the necessary connections, with attendant delays and potential for error.
The present invention is directed to a prepackaged fluid processing module which satisfies the above requirements in a form which is economical to produce and convenient to store. The system is particularly advantageous in medical procedures where a relatively complex fluid circuit is required in conjunction with a multiple pump, sensing and control elements.
The invention is particularly useful in continuous-flow blood fractionation procedures, such as plasmapheresis, wherein plasma (or other blood component) is removed by means of a hollow-fiber filter, and wherein a relatively complex and exacting valving and pumping regimen is required to control blood flow to and from the patient. Accordingly, the invention is illustrated herein in conjunction with a blood fractionation circuit, although it will be appreciated that the invention can be configured to provide other fluid circuits for other medical and non-medical procedures.
Accordingly, it is a general object of the present invention to provide a new and improved disposable fluid processing system.
It is a further object of the present invention to provide a fluid processing system which is modular in construction and wherein the components and interconnections required therein are contained within a single disposable housing.
It is a further object of the present invention to provide a disposable fluid processing module which includes an integral housing for storing the principal components thereof, and wherein a panel of the housing forms, in conjunction with an overlying fluid impermeable plastic sheet member, a low-volume fluid circuit for interconnecting the various components and tubing segments of the system.
It is a further object of the present invention to provide a fluid processing system which is modular for storage, and which can be readily configured for installation on an associated fluid processor apparatus.
It is a further object of the present invention to provide a modular fluid processing system wherein fluid flow is controlled to minimize damage to cellular material processed therein.